Clinical Research Directory

Effectiveness of a Smartphone Chatbot to Improve Exercise Adherence in Older Adults

This randomized controlled trial aims to evaluate the effectiveness of a smartphone-based chatbot in improving adherence to a 12-week home-based multicomponent exercise program in community-dwelling older adults. Participants will be randomly assigned to receive either a chatbot-supported exercise program delivered through Telegram or an equivalent paper-based exercise program. Both groups will perform the same exercise program, including strength, balance, flexibility, and walking exercises. The primary outcome is exercise adherence. Secondary outcomes include physical function, physical activity, participant satisfaction, usability of the chatbot, and adverse events. The study seeks to determine whether chatbot-based support can enhance adherence and improve health outcomes in older adults.

Effects of Cannabidiol on Memory and Attention in Adults Aged 60-70: A Pilot Study

This pilot study aims to investigate the effects of a single oral dose of cannabidiol (CBD) on memory and attention in healthy adults aged 60 to 70 years. CBD is a naturally occurring compound found in cannabis that does not produce the intoxicating effects associated with THC. The main research question is whether CBD can improve episodic memory (the ability to remember previously learned information), working memory (the ability to temporarily hold and use information), and attention compared with placebo. The researchers hypothesize that participants will perform better on memory and attention tasks after receiving CBD than after receiving placebo. The study will involve approximately 50 healthy adults aged 60 to 70 years. Each participant will attend two study sessions, scheduled 14 to 30 days apart. During one session, participants will receive a single oral dose of 25 mg CBD, while during the other session, they will receive a placebo capsule containing no CBD. The order of administration will be randomly assigned, and neither the participants nor the researchers assessing their performance will know which capsule was administered during each session. Memory and attention will be evaluated using standardized memory tests and computer-based cognitive tasks. The findings will provide preliminary evidence on the potential effects of CBD on cognitive functioning in older adults.

Robot-Assisted Tabletop Games for Community-Dwelling Older Adults

This study evaluated a 12-week robot-assisted tabletop game program for community-dwelling older adults in Taiwan. Participants attended one 100-minute group session per week for 12 weeks. The program combined cognitively stimulating tabletop games with guidance from an interactive robot. The robot provided verbal instructions, task prompts, feedback, and turn-taking guidance during the activities. The tabletop games included activities related to orientation, attention, calculation, memory, language, comprehension, and visuospatial abilities. The study used a single-group pre-post design. Participants were assessed before the program and immediately after the 12-week intervention. The study evaluated changes in physical performance, cognitive function, psychological well-being, activities of daily living, depressive symptoms, and frailty. The study was conducted at four community-based long-term care stations in New Taipei City, Taiwan.

Effect of a Two-month Carbohydrate-restricted Diet on Energy Metabolism in a Seniors' Residence

The present study will assess the effects on glucose, ketones and other blood biomarkers fuels, cognition, quality of life, physical activity and well-being of a reduced carbohydrate menu (R-CHO) for 2 months in a population living in a residence for the elderly. This intervention study, identified as the SAGE project (phase 2), follows on from the Ketohome project (phase 1) assessing the feasibility of such a project.

Evaluate the Safety, Tolerability, and Efficacy of UthPeak NMNH (Reduced β-Nicotinamide Mononucleotide Calcium Salt) in Healthy Adult Participants

This randomized, double-blind, placebo-controlled trial evaluated the effects of 90-day NMNH-Ca supplementation on blood NAD⁺ levels, blood phenotypic age, physical function, BMI, and health-related quality of life in healthy adults, together with its safety and tolerability.

Fractal-based Gait Training in Older Adults

The purpose of the study is to investigate the influence of walking with external visual cues on brain adaptations.

The Feasibility, Safety and Tolerability of VR-based Audiovisual Stimulation

This single-session, within-subject, sham-controlled early feasibility study evaluated the safety, tolerability, and feasibility of delivering 40 Hz audiovisual (gamma sensory) stimulation through a virtual reality (VR) headset in cognitively unimpaired older adults and in people with mild cognitive impairment (MCI) due to Alzheimer's disease or mild Alzheimer's disease.

Effect of Vestibular Perceptual Learning on Vestibular Thresholds and Balance

The intervention being studied is a minimal risk perceptual learning protocol delivered in an academic laboratory setting; the goal of the intervention is to improve the perception of passive whole-body tilts and/or translations, as well as balance, by providing feedback following passive tilts or translations of the body. The protocol lasts a total of \~45 days: Day 1 includes a pre-test assessment of perception and balance, as well as 100 repetitions of training, Days 2-7 each include 400 repetitions of training, and Day 6 includes only post-test assessments of perception and balance.

Effects of Astaxanthin Supplementation on Metabolism, Cognition, and Physical Function in Older Adults

This study evaluated whether astaxanthin supplementation affects the body's ability to use fat for energy, cognitive performance, and physical function in healthy older adults. In this randomized, double-blind, placebo-controlled crossover trial, participants received both astaxanthin and a placebo during separate study periods. Neither the participants nor the researchers conducting the assessments knew which treatment participants were receiving during each period. Assessments were used to compare outcomes between the astaxanthin and placebo conditions.

ELITE: Deep Profiling and Algorithmic Polytherapy to Map Individual Response in Healthy Aging

ELITE, Evidence-Based Longevity Interventions and Targeted Engagement, was a randomized, open-label, two-active-arm Phase IIa pilot conducted at Sheba Medical Center in Ramat Gan, Israel. The purpose of ELITE was to characterize individual response to multidomain healthy-aging interventions over approximately eight weeks by combining a clinical measure of muscular, immune and cognitive function with frequent digital monitoring between study visits. The primary outcome was change from baseline to Week 8 in the Muscular-Immune-Cognitive Composite (MIC-C). The study hypothesis was that repeated digital measurements could capture the trajectory of individual response over time and relate that trajectory to clinical change measured at Week 8. Prespecified secondary outcomes included safety, study completion and overall protocol adherence. The protocol-defined intervention was algorithmic polytherapy, integrating a multicomponent pharmacologic and investigational-product regimen with longitudinal digital response monitoring and physician-supervised decision support. In this eight-week pilot, randomized treatment assignments remained fixed. Algorithm-derived response states were generated and reviewed by physicians but did not trigger treatment reassignment. ELITE enrolled 31 community-dwelling adults aged 50 to 80 years without diabetes and with a body-mass index of at least 25 kg/m2. Participants were randomized 1:1 to one of two active treatment regimens. Arm A received metformin plus semaglutide, and Arm B received metformin plus empagliflozin. Both groups also received the investigational AgeBiotics products AB-01 and AB-02 as common components of the multidomain intervention. Individual study products could be interrupted or discontinued for clinical or safety reasons under physician supervision. Between clinic visits, participants completed structured assessments through the ANI.AI application, including tongue, left-eye, right-eye, face and wrist imaging, a short micro-survey and a voice recording. Multispectral measurements of the tongue, face and wrist were collected with a dedicated capture device. These repeated digital measurements were integrated with scheduled clinical, functional, laboratory and multi-omic assessments to create a longitudinal view of biological and functional change during treatment. The ANI.AI platform generated a Composite Response Score (CRS/ADAPT Score) from longitudinal digital biomarker data. The CRS tracked change relative to each participant's baseline and was used within a Bayesian response framework with four prespecified states for physician review: KEEP, AUGMENT, SWITCH and STOPP. The study also included a complementary longitudinal digital health composite to characterize broader multidomain change across repeated digital measurements. These digital measures were prespecified for evaluation in relation to the Week 8 MIC-C clinical outcome.

Cost-Effectiveness Analysis of the Healthy Beat Acupunch Regimen on Physical Fitness, Sleep Quality, and Quality of Life Among Community-Dwelling Older Adults

This study will evaluate the effects and preliminary cost-effectiveness of the Healthy Beat Acupunch (HBA) exercise program among community-dwelling older adults in Thailand. HBA is a 40-minute exercise program that combines gentle body movements with rhythmic tapping along traditional Chinese medicine meridian points. Older adults in the intervention group will participate in HBA exercise three times per week for 6 months. During months 1-3, the sessions will be led by trained exercise leaders. During months 4-6, participants will exercise using a prerecorded HBA video, with personnel present to monitor safety. Participants in the control group will continue their usual daily activities and usual health services without receiving the HBA program during the study period. Physical fitness, sleep quality, and health-related quality of life will be assessed at baseline, 3 months, and 6 months. The study will also compare the direct and indirect costs of the leader-led and video-led phases and conduct a preliminary cost-effectiveness analysis to examine whether the HBA program may be a practical and sustainable health-promotion approach for older adults living in the community.

Vicia Faba Peptides and Resistance Training in the Elderly

This randomized, double-blind, placebo-controlled clinical trial aims to investigate the effects of supplementation with peptides derived from Vicia faba L. combined with supervised resistance training in physically active and inactive older adults. Approximately 100 adults aged 60 years or older will be enrolled. Participants will first be classified as physically active or inactive according to their habitual physical activity level and will then be randomly assigned to receive either Vicia faba L.-derived peptides (2.5 g/day) or placebo. All participants will complete the same supervised resistance training program three times per week for four weeks and will receive nutritional monitoring. Assessments will be performed before and after the intervention to investigate changes in muscle strength and power, body composition, functional mobility, postural balance, physical function, frailty, mental health, quality of life, and cognitive performance. The study will also examine whether habitual physical activity level influences the responses to the combined supplementation and resistance training intervention.

Immersive Group Dance in Virtual Reality and Perceived Social Cohesion in Older Adults

This is a two-arm, parallel-group randomized controlled trial designed to evaluate the effects of an immersive virtual reality (VR)-based group dance program on perceived social cohesion among community-dwelling older adults, compared with a dose-matched conventional light physical activity program. A total of 180 eligible participants (men and women) will be randomized (1:1) to either the VR group dance condition or the control condition. Both interventions are delivered three times per week for five weeks (15 sessions total). The primary outcome is perceived social cohesion, measured using the Perceived Cohesion Scale (PCS) at baseline, post-intervention (week 5), and 30-day follow-up. Sex differences in response to the intervention will be examined as a secondary objective. This study has been approved by the Institutional Ethics Committee of Capital University of Physical Education and Sports (Approval No. IEC/CUPES/345KJB).

Women in Action: A Multicomponent Intervention for Older Women

"Women in Action" is a quasi-experimental, mixed-methods study evaluating a 16-week multicomponent intervention (supervised strength/aerobic/balance training plus psychoeducational and nutrition-focused behavioral workshops) for women aged 55-75 in perimenopause, menopause, and early ageing. The study will assess the feasibility, implementation fidelity, and acceptability of the program, together with its preliminary effects on a single primary outcome (handgrip strength) and secondary physical function, dietary, and psychosocial outcomes, compared with a passive control group receiving no intervention.

Effect of Pentadecanoic Acid Supplementation on Red Blood Cell Health and Biological Aging in Healthy Older Adults

This Phase II randomized, double-blind, placebo-controlled, parallel-group study will evaluate the effects of pentadecanoic acid (C15:0) supplementation on red blood cell (RBC) health and predicted biological age in healthy adults aged 55 years and older. A total of 93 participants will be randomized to receive 200 mg of C15:0, 300 mg of C15:0, or placebo daily for approximately 12 weeks. The primary objective is to assess the effect of C15:0 on red blood cell distribution width (RDW-CV), a marker of RBC health, compared with placebo. Secondary outcomes include measures of inflammation, hematologic and iron metabolism markers, circulating C15:0 levels, biological age-related biomarkers, sleep quality, fatigue, energy, and health-related quality of life. Safety and tolerability will also be evaluated throughout the study.

Disease Modifying Potential of 5mg of Melatonin on Cognition and Brain Health in Aging

The study will examine whether 5mg melatonin (over the counter, OTC) over a 9-month period improves Alzheimer's disease (AD) biomarkers and cognitive function in two groups of individuals: those with mild cognitive impairment (MCI+) and those who are not (MCI-). AD biomarkers will be measured from cerebrospinal fluid (CSF) obtained from lumbar punctures. Cognitive function will be evaluated with routine neuropsychological tests. AS OF AUGUST 2024, THE LUMBAR PUNCTURE PROCEDURES FOR THIS CLINICAL TRIAL HAVE BEEN ELIMINATED. THAT IS, PARTICIPANTS ARE NO LONGER RECEIVING A LUMBER PUNCTURE. BUT ARE CONTINUING TO RECEIVE TWO SEPARATE BLOOD DRAWS FOR BIOMARKER TESTING.

Protein-Distinct Macronutrient-Equivalent Diet 2

The central hypothesis is that the addition of minimally processed lean pork to a healthy plant-forward low ultra-processed diet will enhance nutrient adequacy, promote muscular fitness, and maintain metabolic functions for improved healthspan. A well-designed, randomized, controlled, crossover, feeding study with clinical and molecular mechanistic endpoints is proposed to provide the most definitive level of evidence logistically possible in humans and to establish the role of minimally processed lean pork in healthspan promotion. Utilizing an all-food-provided (dine-in and take-out) design over 18 weeks (rolling recruitment, 8+8, 2w washout), a comprehensive assessment of metabolomics, system biology, physical, and physiological markers that indicate the risk of age-related comorbidities-critical micronutrient deficiency, frailty, metabolic dysfunctions, and cognitive decline, is proposed in upper Midwesterners 65 years and older. A minimally processed plant-forward diet with or without added pork will be compared for over 250 outcome measures using mixed-effects modeling adjusting for covariates in R. n=15/diet/arm i.e., a total starting sample size of n=30 is proposed for 90% power.

The Effect of Reminiscence Therapy in Older Adults

This randomized controlled study examined the effects of reminiscence therapy on psychological well-being and mindfulness among community-dwelling older adults. A total of 90 participants were randomly assigned to an experimental group or a control group. The experimental group received a structured reminiscence therapy program, while the control group received no study intervention. Participants completed baseline assessments before the intervention and post-test assessments immediately after completion of the intervention. The study included 45 participants in the experimental group and 45 participants in the control group.

The Effects of Quercefit® and Ubiqsome™ in Mitigating Inflammation and Promoting Metabolic Health

The goal of this clinical trial is to learn if Quercefit® or Ubiqsome™ can improve markers of healthy aging, blood sugar control, and heart health in older adults. It will also learn about the safety of these supplements. The main questions it aims to answer are: 1. Do Quercefit® or Ubiqsome™ improve blood sugar, cholesterol, and markers of aging compared to a placebo? 2. What side effects, if any, do participants have while taking these supplements? Researchers will compare Quercefit® (500 mg/day), Ubiqsome™ (300 mg/day), and a placebo (a look-alike capsule with no active ingredient). Participants will: 1. Take their assigned capsules (Quercefit®, Ubiqsome™, or placebo) twice daily for 12 weeks 2. Go to a preferred clinic at the start and end of the study for a fasting blood draw Complete at-home tests: 3. Grip strength testing (using a device mailed to them) 4. Online surveys about fatigue and quality of life 5. Report any side effects and keep track of supplement use

Generation Victoria Cohort 2020s: A Statewide Longitudinal Cohort Study of Victorian Children and Their Parents

Generation Victoria (GenV) is a longitudinal, population-based study of Victorian children and their parents that will bring together data on a wide range of conditions ,exposures and outcomes. GenV blends study-collected, study-enhanced and linked data. It will be multi-purpose, supporting observational, interventional, health services and policy research within the same cohort. It is designed to address physical, mental and social issues experienced during childhood, as well as the antecedents of a wide range of diseases of ageing. It seeks to generate translatable evidence (prediction, prevention, treatments, services) to improve future wellbeing and reduce the future disease burden of children and adults. The GenV Cohort 2020s is open to all children born over a two-year period, and their parents, residing in the state of Victoria Australia. The GenV Cohort 2020s is preceded by an Advance Cohort of children born between 5 Dec 2020 and 3 October 2021, and their parents. This comprises all families recruited at GenV's Vanguard hospital (Joan Kirner Women's and Children's) and at birthing hospitals throughout Victoria as GenV scaled up to commence recruiting for the GenV Cohort 2020s. The Advance Cohort have ongoing and full participation in GenV for their lifetime unless they withdraw but may have less complete data and biosamples.

A Study on the Effects of Forest Therapy on Sarcopenia

Purpose: The goal of this study is to investigate the effects of an 8-week Forest Based Intervention program on muscle strength, physical performance, and psychological well-being in older women with sarcopenia. Duration: The program lasts for 8 weeks, with 2 sessions per week (16 sessions total). Each session is approximately 180 minutes. Activities: Participants will take part in a structured program at the Caoling Shibi Forest Healing Base in Yunlin. The program includes forest trail walking, resistance training using elastic bands, stretching, and sensory activities such as aromatherapy and deep breathing. Assessments: Researchers will evaluate physical indicators and psychological well-being before the program, immediately after, and at a 1-month follow-up. Goal: We hope to determine if combining structured exercise with the forest environment can effectively improve the health and quality of life for older women with sarcopenia.

Land vs. Water Exercises on Performance and Swimming Behavior in Older Adults

This study aims to investigate the effects of an 8-week combined land and aquatic exercise program (conducted 3 days per week) on physical performance, recreational swimming behaviors, and water-related risk perceptions in older adults. Physical performance is evaluated using handgrip strength and the 30-second chair sit-up test (30CST), while swimming behaviors and water-related risk perceptions are assessed via structured questionnaires.

Sandplay-Act. Older: Structured Sandplay Activity for Older Individuals

This research was planned to determine the effect of structured sandplay activities on positive and negative affect and levels of meaning in life in elderly individuals. The research will be conducted as a single-blind, randomized controlled trial with a pre-test, post-test design at the Gül Kokulu Çınarlar Vefa Konağı of the Isparta Municipality Health Affairs Directorate between July 2026 and July 2027. Prior to the research, ethical committee approval and institutional permission for implementation will be obtained. The research population consists of 400 individuals registered with the institution. The sample will consist of 60 individuals (30 in the intervention group and 30 in the control group) who meet the inclusion criteria, are selected using block randomization, and provide informed consent. The control group will receive no intervention; a pre-test will be administered on the first day, and a post-test will be administered on the day the intervention for the experimental group ends. The intervention group will participate in sandplay activities twice a week for a total of four sessions; a pre-test will be administered on the first day, and a post-test will be administered in the last session. Data collection is planned for the period between July 2026 and July 2027 using the Personal Information Form (PIF), the Positive-Negative Affect Scale (PANAS), and the Meaning in Life Scale (MLS). Data will be analyzed using the SPSS (Statistical Program for Social Sciences) statistical analysis package, and statistical significance will be accepted at p \< 0.05.

Peanut Butter and Brain Health

Healthy foods, including peanuts, may improve brain function, which is essential for cognitive and metabolic health, and may contribute to improved food intake regulation. It is therefore important to investigate the specific effects of peanut butter on cerebral blood flow responses, as well as the potential associated functional benefits. The researchers hypothesize that long-term peanut butter consumption improves vascular function in the brain, thereby enhancing cognitive performance and appetite control in middle aged and older adults. Objective: The primary objectives are to investigate in middle aged and older men and women the effect of 16-week peanut butter consumption on brain vascular function, while we will also assess changes in cognitive performance and appetite-related brain reward activity (secondary objectives). Cerebral blood flow responses (brain vascular function) will be non-invasively quantified by the non-invasive gold standard magnetic resonance imaging (MRI)-perfusion method Arterial Spin Labeling (ASL).Study design: This intervention study will have a randomized, controlled, cross-over design. The total study duration will be 40 weeks, including two 16-week interventions, separated by a washout period of at least 8 weeks. Study population: Forty-five middle-aged and older men and women (aged 45-75 years) without a history of cardiovascular diseases or complaints will participate. This population is expected to have a decreased cerebral blood flow at baseline and are also at increased risk of cognitive impairment, allowing for improvement by the intervention. Intervention: Study participants will receive, in random order, 45 g of peanut butter daily (peanut intervention) or no peanut butter (control) for a total of 16 weeks, separated by a wash-out period of at least 8 weeks. Main study parameters/endpoints: At baseline, first anthropometric measurements will be performed and blood pressure will be determined. In addition, a fasting blood sample will be drawn. Another fasting blood sample will be drawn at eight weeks, while participants have to attend the research facilities to perform follow-up measurements after sixteen weeks. The primary endpoint is the difference at follow-up in the cerebral blood flow response between peanut butter intervention and control periods. Cognitive performance will be assessed, while the researchers will also focus on appetite-related brain reward activity (secondary outcomes).